ADMINISTRATIVE COUNCIL
Decisions of the Administrative Council
Decision of the Administrative Council of 30 November 1979 amending the Implementing Regulations to the European Patent Convention
THE ADMINISTRATIVE COUNCIL OF THE EUROPEAN PATENT OFFICE
Having regard to the European Patent Convention (hereinafter referred to as the "Convention"), and in particular Article 33, paragraph 1(b), thereof, On a proposal from the President of the European Patent Office,
HAS DECIDED AS FOLLOWS:
Article 1
The following text shall be substituted for Rule 28 of the Implementing Regulations:
"Rule 28
Requirements of European patent applications relating to micro-organisms
(1) If an invention concerns a microbiological process or the product thereof and involves the use of a micro-organism which is not available to the public and which cannot be described in the European patent application in such a manner as to enable the invention to be carried out by a person skilled in the art, the invention shall only be regarded as being disclosed as prescribed in Article 83 if:
(a) a culture of the micro-organism has been deposited with a recognised depositary institution not later than the date of filing of the application;
(b) the application as filed gives such relevant information as is available to the applicant on the characteristics of the microorganism;
(c) the depositary institution and the file number of the culture deposit are stated in the application.
(2) The information referred to in paragraph 1(c) may be submitted: (a) within a period of sixteen months after the date of filing of the application or, if priority is claimed, after the priority date;
(b) up to the date of submission of a request for early publication of the application;
(c) within one month after the European Patent Office has communicated to the applicant that a right to inspection of the files, pursuant to Article 128, paragraph 2, exists. The ruling period shall be the one which is the first to expire. The communication of this information shall be considered as constituting the unreserved and irrevocable consent of the applicant to the deposited culture being made available to the public in accordance with this Rule.
(3) The deposited culture shall be available upon request to any person from the date of publication of the European patent application and to any person having the right to inspect the files under the provisions of Article 128, paragraph 2, prior to that date. Subject to the provisions of paragraph 4, such availability shall be effected by the issue of a sample of the micro-organism to the person making the request (hereinafter referred to as the "requester"). Said issue shall be made only if the requester has undertaken vis-à-vis the applicant for or proprietor of the patent:
(a) not to make the deposited culture or any culture derived therefrom available to any third party before the application has been refused or withdrawn or is deemed to be withdrawn or, if a patent is granted, before the expiry of the patent in the designated State in which it last expires;
(b) to use the deposited culture or any culture derived therefrom for experimental purposes only, until such time as the patent application is refused or withdrawn or is deemed to be withdrawn, or up to the date of publication of the mention of the grant of the European patent. This provision shall not apply insofar as the requester is using the culture under a compulsory licence. The term "compulsory licence" shall be construed as including ex officio licences and the right to use patented inventions in the public interest.
(4) Until the date on which the technical preparations for publication of the application are deemed to have been completed, the applicant may inform the European Patent Office that, until the publication of the mention of the grant of the European patent cr until the date on which the application has been refused or withdrawn or is deemed to be withdrawn, the availability referred to in paragraph 3 shall be effected only by the issue of a sample to an expert nominated by the requester.
(5) The following may be nominated as an expert:
(a) any natural person provided that the requester furnishes evidence, when filing the request, that the nomination has the approval of the applicant;
(b) any natural person recognised as an expert by the President of the European Patent Office. The nomination shall be accompanied by an undertaking from the expert vis-à-vis the applicant; paragraph 3 (a) and (b) shall apply, the requester being regarded as a third party.
(6) For the purposes of paragraph 3, a derived culture is deemed to be any culture of the micro-organism which still exhibits those characteristics of the deposited culture which are essential to carrying out the invention. The undertaking referred to in paragraph 3 shall not impede a deposit of a derived culture, necessary for the purpose of patent procedure.
(7) The request provided for in paragraph 3 shall be submitted to the European Patent Office on a form recognised by that Office. The European Patent Office shall certify on the form that a European patent application referring to the deposit of the micro-organism has been filed, and that the requester or the expert nominated by him is entitled to the issue of a sample of the microorganism.
(8) The European Patent Office shall transmit a copy of the request, with the certification provided for in paragraph 7, to the depositary institution as well as to the applicant for or the proprietor of the patent.
(9) The President of the European Patent Office shall publish in the Official Journal of the European Patent office the list of depositary institutions and experts recognised for the purpose of this Rule."
Article 2
The following Rule 28a shall be inserted in the Implementing Regulations:
"Rule 28a
New deposit of a micro-organism
(1) If a micro-organism deposited in accordance with Rule 28, paragraph 1, ceases to be available from the institution with which it was deposited because:
(a) the micro-organism is no longer viable, or
(b) for any other reason the depositary institution is unable to supply samples, and if the micro-organism has not been transferred to another depositary institution recognised for the purposes of Rule 28, from which it continues to be available, an interruption in availability shall be deemed not to have occurred if a new deposit of the micro-organism originally deposited is made within a period of three months from the date on which the depositor was notified of the interruption by the depositary institution and if a copy of the receipt of the deposit issued by the institution is forwarded to the European Patent Office within four months from the date of the new deposit stating the number of the application or of the European patent.
(2) In the case provided for in paragraph 1(a), the new deposit shall be made with the depositary institution with which the original deposit was made; in the cases provided for in paragraph 1(b), it may be made with another depositary institution recognised for the purposes of Rule 28.
(3) Where the institution with which the original deposit was made ceases to be recognised for the purposes of the application of Rule 28, either entirely or for the kind of micro-organism to which the deposited micro-organism belongs, or where that institution discontinues, temporarily or definitively, the performance of its functions as regards deposited microorganisms, and the notification referred to in paragraph 1 from the depositary institution is not received within six months from the date of such event, the three-month period referred to in paragraph 1 shall begin on the date on which this event is announced in the Official Journal of the European Patent Office.
(4) Any new deposit shall be accompanied by a statement signed by the depositor alleging that the newly deposited micro-organism is the same as that originally deposited.
(5) If the new deposit provided for in the present Rule has been made under the provisions of the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure of 28 April 1977, the provisions of that Treaty shall prevail in case of conflict."
Article 3
The President of the European Patent Office shall transmit a certified copy of this Decision to the signatory States to the Convention and to the States which accede thereto.
Article 4
This Decision shall enter into force on 1 June 1980.
Done at Munich, 30 November 1979.
For the Administrative Council
The Chairman
G. VIANES